Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-25 @ 2:54 AM
NCT ID:
NCT03481933
Eligibility Criteria:
Inclusion Criteria:
SD-Patients:
1. Patients fulfilling the international diagnosis criteria of SD (Gorno-Tempini et al., 2011): fluent speech, single word comprehension and naming deficit, +/- object recognition deficits, +/- surface agraphia or alexia. Absence of phonemic paraphasias, agrammatism and word apraxia.
2. Age \> 18 years old.
3. Patients have given their informed written consent.
4. Affiliation to a social security regime.
Healthy controls:
1. Age \>18 years old
2. Subjects have given their informed written consent.
3. Subjects selected according to the matching criteria (age, sex, handedness and number of years of education).
4. Affiliation to a social security regime
Exclusion Criteria:
SD-Patients:
1. MADRS ≥ 20 (major depressive syndrome according to the DSM-IV-R criteria)
2. MMS \< 10/30
3. FAB \< 7/18
4. BDAE aphasia severity rating scale \< 3/5
5. Patients not having French as their mother tongue
6. Other neurological pathology or general disorder or major physical deficits than can interfere with cognitive functioning
7. MRI or PET contraindication, 18-FDG contraindication
8. Cerebral MRI data compatible with a pathological process other than the one related to SD (Vascular, traumatic, tumoral, infectious, or metabolic brain injury). A moderate or discrete leukoaraiosis will not be considered as a non- inclusion criterion (patients with a Fazekas and Schmidt \[Fazekas et al., 1998a; fazekas et al., 1998b\],stage \>2 for hypersignals of the periventricular and deep white matter will not be included)
9. The patient should not participate simultaneously in another brain therapeutic trial (possibility of bias between stimulation and evaluation of the effect on language / semantic processes)
10. \- tDCS contraindications: epilepsy antecedents, presence of epilepsy risk factors (known alcoholism or metabolic troubles, antecedents of head injury or chirurgical intervention on the brain or the skull), skin lesions of the scalp, skull metal implants.
11. \- Patients under curatorship or tutorship
12. \- Women whose pregnancy is known or who do not have effective contraception if they are of reproductive age (checked by urinary test), breastfeeding.
Healthy controls:
1. Subjects not having French as their mother tongue
2. Subjects having a neurological or psychiatric disease or major deficits than can interfere with cognitive functioning
3. MRI or PET contraindication, 18-FDG contraindication
4. Women whose pregnancy is known or who do not have effective contraception if they are of reproductive age (checked by urinary test), breastfeeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03481933
Study Brief:
Protocol Section:
NCT03481933